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The National Institute for Clinical Excellence

NICE, the special health authority set up last April, will provide patients, health professionals1 and the public in England and Wales with authoritative, robust and reliable guidance on current 'best practice'. This guidance will cover both individual health technologies, including pharmaceuticals, medical devices, diagnostic techniques and procedures, and the management of specific conditions.

NICE has been established to help health professionals in the NHS give their patients the best possible healthcare within the resources available.

All health professionals want to give their patients the best possible care. However, these same professionals across the world face two particular difficulties

The pace of scientific and clinical discovery is so great that it is impossible for individual health professionals to remain at the forefront of knowledge across the wide range of subjects with which they deal.

The demand for health care  due to past successes, the emergence of effective new technologies and the fact that we don't stop using less effective technologies  has exceeded the available financial and human resources.

As a result, every healthcare system in the world is struggling to find solutions to these problems. In Britain, as elsewhere, these two fundamental difficulties have given rise to their own problems:

Health professionals have sometimes adopted new health technologies, or clinical management programmes, without adequate evidence of their clinical or cost effectiveness.

Health professionals have sometimes persisted with out-of-date technologies or management programmes that have been superseded by newer developments.

Health professionals have sometimes been too slow to introduce new methods of practice, even when these have been shown to be clinically effective and give value for money.

Although some of the 'clinical guidelines' produced (by individuals, groups or professional bodies) have been shown to be useful and effective, many others have been of an inadequate or indeterminate quality. There has been no clear way of knowing into which category the guidelines you have in front of you fall. There has also been no clear way of getting those effective guidelines into practice across the country.

As a result of these issues, patients seeking care from the NHS have experienced unacceptable inequalities in the availability of care (so-called 'post-code' prescribing), unacceptable variations in the quality of care, and wastage of both human and financial resources.

NICE will provide NHS health professionals, patients and the public with three types of guidance:

The results of appraisals of new and existing health technologies.

Clinical guidelines, defined as 'systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances', for the management of specific conditions.

Simple methods of clinical audit to support the Institute's guidance on the use of individual technologies and the adoption of clinical guidelines.

NICE is and will remain a relatively small organisation (2030 staff in total eventually). It has been described as a 'virtual organisation'. Most of its work will be built on a network, linking the large but fragmented community of academic, professional and user initiatives.

Technology appraisals: The DoH and the National Assembly for Wales select technologies for appraisal by NICE. NICE then follows a transparent and well structured process for its appraisals (outlined in Figure 1, below), giving appropriate interested parties the opportunity to submit evidence, to comment on draft conclusions, and to appeal to a panel independent of those involved in the original judgment.

Figure 1: Diagrammatic representation of NICE's appraisal process

It would be quite impractical in the immediate future to attempt to appraise all technologies that are, or are about to be, available. When fully established, NICE expects to appraise around 30 technologies each year.

The results of the appraisal process will provide patients, health professionals and health service managers with a single authoritative source of advice.

NICE will also, when appropriate, prepare guidance for users and carers, consulting with appropriate patient groups on the best format and means of dissemination. This guidance will explain the nature of the clinical recommendations, the implications for the standards that patients can expect, and the broad nature of the evidence on which the recommendations are based.

Guidelines and audit: Clinical guidelines are complementary to, not a replacement for, the knowledge and skills of experienced health professionals. Nevertheless, there is strong research evidence to suggest that, in practice, clinical guidelines can change the process of care and health outcomes.

The Institute's clinical guidelines will be based on the best available evidence and expert professional advice. They will take into account both the clinical and the cost effectiveness of the measures recommended and they must be both practical and affordable. Clinical guidelines will be developed from different sources:

Existing (or recently constructed) clinical guidelines that have been prepared by others. Such sources will only be used if they fulfil the Institute's own explicit criteria for quality and content.

Where NICE identifies specific unmet needs, it will commission guidelines from start to finish.

Protocols for the appropriate referral of patients from primary to secondary care.

NICE will establish a Clinical Guidelines Committee to advise and assist in the guidelines work programme. The committee will comprise health professionals (particularly those with expertise in guidelines construction) and relevant patient interests.

Its terms of reference will include responsibility for ensuring the quality of the Institute's clinical guidelines, advising on the commissioning of new guidelines, developing parallel clinical audit methodologies, and assisting in guideline implementation.

NICE is currently establishing its processes for the assessment and development of clinical guidelines, including the process for appointing members to a Clinical Guidelines and Audit Committee.

The Institute will develop and promote simple methods of clinical audit. These audits will relate to both the Institute's guidance on technologies and its clinical guidelines.

Work programme: The NICE work programme has been widely published and is described in detail on the NICE website (https://www.nice.org.uk).

The Institute's website also contains all the latest information on NICE and its work.

National Institute for Clinical Excellence

Set up

1st April 1999

Objectives

To provide the NHS (patients, health professionals and the public) in England & Wales with authoritative, robust and reliable guidance on current 'best practice'